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impax generics - felbamate (unii: x72rbb02n8) (felbamate - unii:x72rbb02n8) - felbamate 400 mg - felbamate tablets, usp are not indicated as a first line antiepileptic treatment (see warnings ). felbamate tablets, usp are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. if these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate tablets, usp can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with lennox-gastaut syndrome in children. felbamate is contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. it should not be used in patients with a history of any blood dysc

United States - English - NLM (National Library of Medicine)

impax generics - risedronate sodium hemi-pentahydrate (unii: hu2yaq274o) (risedronic acid - unii:km2z91756z) - risedronate sodium delayed-release tablets are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see clinical  studies (14.1) ]. the optimal duration of use has not been determined. the safety and effectiveness of risedronate sodium delayed-release tablets for the treatment of osteoporosis are based on clinical data of one year duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. risedronate sodium delayed-release tablets are contraindicated in patients with the following conditions: - abnormalities of the esophagus which delay esophageal emp

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impax generics - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). the efficacy of divalproex sodium extended-release tablets are based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania [see clinical studies

United States - English - NLM (National Library of Medicine)

impax generics - glyburide (unii: sx6k58tvwc) (glyburide - unii:sx6k58tvwc), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - glyburide 1.25 mg - glyburide and metformin hydrochloride tablets, usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glyburide and metformin hydrochloride tablets are contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73m2 ) (see warnings and precautions ). - known hypersensitivity to metformin hydrochloride or glyburide. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. - concomitant administration of bosentan. 

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impax generics - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 0.1 mg - desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. desmopressin acetate may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention. desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. desmopressin a

United States - English - NLM (National Library of Medicine)

impax generics - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - fluocinonide 0.5 mg in 1 g - fluocinonide cream usp, 0.05% (emulsified base) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. fluocinonide cream, usp 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamicpituitary- adrenal (hpa) axis suppression and cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.  hpa axis suppression, cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. administration of topical cortico

United States - English - NLM (National Library of Medicine)

impax generics - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24), simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - ezetimibe 10 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. ezetimibe and simvastatin tablets are indicated for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), triglycerides (tg), and non-high-density lipoprotein cholesterol (non-hdl-c), and to increase high-density lipoprotein cholesterol (hdl-c) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. ezetimibe and simvastatin tablets are indicated for the reduction of elevated total-c and ldl-c in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments

United States - English - NLM (National Library of Medicine)

impax generics - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 1.25 mg in 3 ml

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impax generics - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 5 mg - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, lll1 as follows: generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three o

United States - English - NLM (National Library of Medicine)

impax generics - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - aspirin 25 mg